11 results
• Primary- To determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adult subjects with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).• Secondary-To evaluate the safety, efficacy, and…
The primary objective of the study is to assess the safety of 1 course of blinatumomab added to the Interfant-06 backbone in infants with newly diagnosed ALL. The secondary objectives are: • to assess the feasibility• to define the preliminary…
Primary objective:-To assess the proportion of patients that achieve MRD negative response (by PCR/FCM) after the first consolidation phase including blinatumomab.Secondary objectives:-To assess the MRD level following induction chemotherapy-To…
Primary:The primary objective is to assess the efficacy of LY2951742 300 mg every 30 days compared with placebo in reducing the frequency of weekly cluster headache attacks in patients with episodic cluster headache. The primary outcome measure will…
Primary objective:The primary objective is to assess the efficacy of LY2951742 300 mg every 30 days compared with placebo in reducing the frequency of weekly cluster headache attacks in patients with chronic cluster headache. The primary outcome…
PrimaryTo test the hypothesis that at least 1 dose of LY2951742 (120 or 240 mg/month) is superior to placebo in the prevention of migraine headache in patients with episodic migraine.Key Secondary ObjectivesIf LY2951742 (120 or 240 mg/month) is…
The primary objective of this study is to evaluate the safety of open-label galcanezumab within the context of expected medical practice in eligible patients with episodic or chronic cluster headache. The secondary endpoints are to characterize the…
Primary:• To compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy to EFS of subjects receiving standard of care (SOC) chemotherapy• To compare overall survival (OS) of blinatumomab…
The primary objective is to improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2A-rearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the…
Primary :• To evaluate the safety and tolerability of blinatumomab incombination with AMG 404 in adults with R/R B-ALL• To estimate the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of AMG 404 when combined with cIV…
Primary:Dose Escalation• Evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)• Determine the maximum tolerated dose (MTD) and…